Kornimate/medical-research-clean huggingface dataset:
an observational study to assess the canagliflozin treatment in type 2 diabetes mellitus in a usual clinical practice in canada

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to evaluate canagliflozin use in the treatment of type 2 diabetes mellitus (t2dm) and generate evidence of its effectiveness, safety and patient-reported outcome (pro) in a usual clinical practice in canada.

this is a prospective, non-interventional, nation-wide, multicenter (more than one study site) study to evaluate the treatment of t2dm with canagliflozin in a usual clinical practice in canada. approximately 535 participants will be enrolled into this study. the planned study duration for each participant will be 12 months \[plus or minus (+/-) 4 weeks\], including 4 study visits in accordance with the usual clinical practice: enrollment and visits at 3, 6 and 12 months (+/- 4 weeks). participants will primarily be observed for effectiveness, safety and pro over an observational period of 12 months.

Eligibility criteria:
inclusion criteria: * participant must have a diagnosis of type 2 diabetes mellitus (t2dm) with glycosylated hemoglobin (hba1c) of greater than or equal to (\>=) 7 percent (%) at baseline * participant must be on a stable antihyperglycemic treatment regimen for at least 30 days prior to canagliflozin initiation * participant must have estimated glomerular filtration rate (egfr) \>=60 milliliter (ml)/minute(min)/1.73 meter\^2 (m\^2) * must be a sodium-glucose co-transporter 2 (sglt2) inhibitors naive participant initiating canagliflozin treatment prior to study enrollment * participant must provide a written consent for data collection by signing an icf indicating that they understand the procedures for data collection and are willing to participate in the study exclusion criteria: * participants with a history of sglt2 inhibitors use (canagliflozin, empagliflozin, dapagliflozin or any other sglt2 inhibitor) * participants with a history of diabetic ketoacidosis (dka), autoimmune diabetes (example, type 1 diabetes mellitus \[t1dm\] and latent autoimmune diabetes in adults \[lada\]), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy * participants who received an investigational drug (including vaccines) within 3 months before the initiation of canagliflozin * participant who is currently enrolled or plans to enroll in an investigational study * participant who is pregnant or breastfeeding or planning to become pregnant or breast feed during the study

Keywords: diabetes mellitus type 2 canagliflozin observational study
preliminary study of safety and efficacy of nanocrystalline silver cream in atopic dermatitis (eczema)

Conditions: Atopic Dermatitis; Eczema

Summary: nanocrystalline silver (very small particles of silver) is the active ingredient in acticoat dressings, which have been approved for the treatment of burns and other wounds. silver has been used for decades as an effective antimicrobial agent. in animal studies, nanocrystalline silver cream (npi) has also demonstrated anti-inflammatory activity. thus, nanocrystalline silver cream is being evaluated in the treatment of inflammatory skin conditions such as atopic dermatitis (eczema). approximately 180 study subjects with a definitive diagnosis of mild to moderate eczema will be enrolled in this study. subjects will be randomly assigned to treatment with placebo, 0.5% npi or 1% npi for the 6-week treatment period. assessments of treatment effect and safety will be performed weekly. upon completion of the study, subjects may be eligible for 12 weeks of open-label treatment with 1% npi.


Eligibility criteria:
* male or female, any race, 18 to 65 years of age. * females must be post-menopausal, surgically sterile, or if of child-bearing potential, not pregnant (confirmed by test) and using an adequate method of birth control. * subjects must have eczema that covers a minimum of 5% total body surface area. * subjects must agree not to use other eczema medications for the 6-week study treatment period. * subjects must not be enrolled in another investigational drug study. * subjects must not be allergic to silver or cocoa butter.

Keywords: atopic dermatitis eczema
development a rhesus type compatibility test by means of an antibody able to recognize rh1 antigen grafted on a biochip

Conditions: Rh Incompatibility Reaction

Summary: every year, several millions of red cell concentrates are transfused. for each of them, a pretransfusional compatibility test is performed. in france, an abo compatibility test at the patient's bedside is performed, but rhesus compatibility is not yet checked. however, rhesus antigens are very immunogenic and could lead to rh incompatibility or rh disease. the objective of abordage project is to develop another biochip that specifically captures rbcs according the presence of the rh1 antigen (also known as d antigen) at their surface.

every year, several millions of red cell concentrates are transfused. for each of them, a pretransfusional compatibility test is performed. in france, an abo compatibility test at the patient's bedside is performed, but rhesus compatibility is not yet checked. however, rhesus antigens are very immunogenic and could lead to rh incompatibility or rh disease. rh incompatibility occurs when a woman with rh-negative blood type is exposed to rh-positive blood cells. this exposure leads to the sensitization of the women who develop anti-rh immunoglobulin g (igg). this immunization is one cause of the hemolytic disease of newborns (hdn). hdn results from an incompatibility between mother's blood and fetus' blood. it happens when fetal red blood cells (rbcs) present antigens inherited from the father but missing from the mother. consequence of this incompatibility is the fetal rbcs destruction by mother's antibodies. antibodies could be natural, like immunoglobulin m (igm) anti-a or anti-b from the abo system, or from an immunization. rh incompatibility results from 2 main mechanisms. the first one is when a pregnancy rh-negative woman is exposed to fetal rh-positive rbcs. rh incompatibility leads to anemia (mild to severe) or ultimately to the in utero death. the second occurs when rh incompatible blood is transfused. this is the subject of this communication. the investigators previously develop biochips and optical device to realize automatic abo compatibility test at the patient's bedside (references to the citation field). based on this previously project, the goal of abordage project is to develop another biochip based on selective blood capture. the abordage chip has to specifically capture rbcs according the presence of the rh1 antigen (also known as d antigen) at their surface.

Eligibility criteria:
inclusion criteria: * donor inclusion criteria will be those of the etablissement français du sang exclusion criteria: * donor exclusion criteria will be those of the etablissement français du sang
biological monitoring by a nurse for heart failure patients.

Conditions: Heart Failure

Summary: the aim of this study is to evaluate the feasibility and safety of delegating remote biological monitoring in post-hospitalization for cardiac decompensation by a heart failure nurse.

chronic heart failure is a major public health issue in france. it is the leading cause of hospitalisation in people over 65 years of age and results in many costly and potentially avoidable hospital stays. one third of patients are readmitted to hospital within 3 months of discharge. a remote monitoring programme and natriuretic peptide monitoring during this vulnerable period can help improve patient management, reducing rehospitalisation rates, emergency room visits and mortality. given the increasing pressure on already limited healthcare resources, it is important to examine the delegation of care to specialist nurses, as well as their safety. this study aims to evaluate the feasibility and safety of delegating remote biological monitoring in post-hospitalization for cardiac decompensation by a heart failure nurse.

Eligibility criteria:
inclusion criteria: * patient ≥18 years old, * patient hospitalised for heart failure and discharged, * glomerular filtration rate at discharge \> 20ml/min/1.73m², * patient informed and agree to participate, * patient able to carry out the follow-up proposed by the cardiology department. exclusion criteria: * cognitive disorders with codex test category c and d, * barrier of the language, * psychiatric disorder that may interfere with treatment, * major surgery scheduled within 3 months, * excessive alcohol or drug use with no desire to withdraw * cardiac amyloidosis, * terminal heart failure, * patient discharged to specialised care and rehabilitation department, * any disease other than cardiac with a life expectancy of less than 1 year according to the investigator, * patient under guardianship,

Keywords: heart failure biological monitoring heart failure nurse post-hospitalization
effect of tegaserod on gastric emptying in patients with diabetic gastroparesis

Conditions: Gastroparesis; Diabetes

Summary: this study will assess gastric emptying in patients with symptoms of diabetic gastroparesis treated with tegaserod over 2 weeks.


Eligibility criteria:
inclusion criteria: * females and males 18 to 75 years of age * history of type i or type ii diabetes mellitus for more than 3 years * history of upper gastrointestinal symptoms consistent with diabetic gastroparesis * hemoglobin a1c \< 9.5% * delayed gastric emptying exclusion criteria: * abnormal endoscopy finding that can explain the presence of gastroparesis symptoms * medical conditions affecting gastric emptying * a clinically significant medical condition that would interfere with the patient completing the trial * clinically significant abnormal creatinine level * known allergies to the same class of drug and/or allergies to eggs * severe obesity other protocol-defined inclusion/exclusion criteria may apply.

Keywords: tegaserod diabetes diabetic gastroparesis gastric emptying gastric retention electrogastrography
the preventive efficacy of carvedilol on cardiac dysfunction in duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy; Cardiomyopathies

Summary: purpose this cardiac dysfunction in patients with duchenne muscular dystrophy is associated with minor cardiac damage as indicated by elevation of plasma cardiac troponin i (ctni). the purpose of this study is to investigate whether the administration of carvedilol can suppress the minor cardiac damage and prevent deterioration of cardiac function.

the life span in patients with duchenne muscular dystrophy has been extending due to the development of artificial respiratory devices. according to that, the ratio of cardiac dysfunction as a cause of death has been increasing. this cardiac dysfunction was associated with minor cardiac damage as indicated by elevation of plasma cardiac troponin i (ctni). furthermore, and the detection rate of ctni plasma as revealed to be correlated with the deterioration speed of lv dysfunction assessed by serial echocardiography measurements. accordingly, if this minor cardiac damage is suppressed, it is postulated that the progression of cardiac dysfunction can be stopped. in the cases with ventricular arrhythmia and tachycardia, we found plasma ctni became undetectable after administration of beta-blocker. accordingly, we investigate whether administration of beta-blocker, carvedilol can persistently suppress the minor cardiac damage and lead to suppress the deterioration of lv function. note that his study preventive study for preserved to moderate lv dysfunction and is not intended to the beta-blocker treatment for severe lv dysfunction. because we assume that the mechanism of elevation of ctni is different; spontaneous in preserved to mild lv dysfunction in patients but lv wall stress in severe lv dysfunction in patients with duchenne muscular dystrophy.

Eligibility criteria:
inclusion criteria: male patients with duchenne muscular dystrophy are required to meet the following criteria: 1. aged ８ to 45 years 2. positive plasma cardiac troponin i (0.06ng/ml) at least 4 blood measurement in every 3 month. 3. left ventricular ejection fraction \>30% by echocardiography assessment 4. written informed consent exclusion criteria: patients with the following conditions will be excluded from the study: 1. left ventricular ejection fraction \<30% 2. no plasma ctni elevation 3. beta-blocker is already administered without measurement of plasma ctni 4. contraindication against treatment with β blockers 5. any other serious disease that could potentially complicate the management and follow-up protocols

Keywords: adrenergic beta-antagonists duchenne muscular dystrophy cardiomyopathies troponin i
effect of eltrombopag plus g-csf on human cd34+ cell mobilization in multiple myeloma patients undergoing asct

Conditions: Multiple Myeloma

Summary: eltrombopag may improve the cell collection available for autologous stem cell transplant(asct). the overall goal is to determine if adding eltrombopag to the standard asct will increase the number of blood cells collected and reduce the number of times blood needs to be collected. this study will also determine the highest dose of eltrombopag that can be used without causing serious side effects.

subjects will receive standard treatment for autologous stem cell transplant. subjects will be assigned to receive no eltrombopag or one of three dose levels of eltrombopag. subjects will receive oral eltrombopag on days 2-15 of treatment.

Eligibility criteria:
inclusion criteria: * multiple myeloma * stable or responsive disease after at least 2 cycles of conventional chemotherapy * slated to undergo autologous peripheral blood stem cell transplant * normal organ and marrow function exclusion criteria: * myocardial infarction within 6 months of treatment * receiving other study agents * pregnant or breastfeeding * uncontrolled intercurrent illness * evidence of active or recent history of thromboembolic disease * previous history of primary platelet disorder or bleeding disorder * history of a different malignancy unless disease free for at least 5 years

Keywords: asct g-csf
post-marketing surveillance study of micardis® plus in patients with hypertension

Conditions: Hypertension

Summary: study to evaluate efficacy and tolerability of micardis® plus under usual daily-practice prescribing-conditions


Eligibility criteria:
inclusion criteria: * adult (age \>= 18 years) males and females for whom a medical antihypertensive therapy is indicated exclusion criteria: * age \< 18 years
dual-site lv pacing in crt non responders: multicenter randomized trial

Conditions: Heart Failure

Summary: cardiac resynchronization therapy (crt) is an effective treatment of heart failure (hf) refractory to optimal medical management, in presence of a depressed left ventricular (lv) ejection fraction and a wide qrs complex. it is mainly limited by a high proportion of non-responders. attempts have been made, in small studies, to increase the number of stimulation sites in order to optimize the resynchronization therapy. v3 is a planned multicenter, randomized trial whose objective is to evaluate the clinical benefit conferred by the addition of a second endocardial or epicardial lv lead in non-responders after at least 6 months of standard biventricular stimulation. the v3 trial will examine the clinical benefit conferred by the addition of a second lv lead in non-responders compared to standard crt.


Eligibility criteria:
inclusion criteria: * age greater than 18 years * recipient of a crt-p or crt-d system for greater than 6 for standard indications, including lv ejection fraction greater than 35 percent and new york heart association (nyha) functional class iii or iv * optimized biventricular stimulation and medical therapy since implantation of the system * presence of sinus rhythm, or atrial fibrillation with spontaneous or induced complete atrio-ventricular block * greater than 93 percent lv stimulation since the last device interrogation, with a lv capture threshold less than 5.0 volts/0.5 milliseconds * unchanged or worsened clinical status by crt, according to the hf composite endpoint described by m. packer, in absence of a reversible cause * signature of a written, informed consent to participate in the trial exclusion criteria: * lv lead location in the great cardiac vein * life-expectancy less than 1 year due to concomitant, non-cardiovascular disorders * chronic renal dialysis * concomitant disorder which might interfere with the results of the v3 trial * blood systolic pressure greater than 180 millimeters of mercury (mmhg) or diastolic pressure greater than 95 mmhg despite optimal medical management * history of stroke, myocardial infarction or unstable angina pectoris within the last 3 months * presence of correctible valvular disease * subject unable to attend follow-up at the investigative center or unable, for physical or mental reasons, to comply with the trial's procedures, or to sign the informed consent * subject is pregnant * subject participates in another research project

Keywords: heart failure cardiac resynchronization therapy biventricular stimulation multisite stimulation non responders
investigate risperidone for the treatment of schizophrenia in adolescents

Conditions: Schizophrenia

Summary: a clinical study to evaluate the efficacy, safety and tolerability of two dose ranges of risperidone (1 to 3 mg/day, and 4 to 6 mg/day) versus placebo (an inactive substance like a sugar pill) in adolescents (aged 13 to 17 years) with schizophrenia (i.e. abnormal behavior and thoughts). the study duration is about 6 to 7 weeks.

subjects will be aged 13 to 17 years with a diagnosis of schizophrenia. on enrollment, subjects will be assigned to receive 1 of 3 treatments (oral placebo tablets, oral risperidone tablets 1 to 3 mg, or oral risperidone tablets 4 to 6 mg), which will be administered daily for 6 weeks. study medication will be increased to within the target dosage range during the first 7 days and then further increased until the maximum tolerated dose is achieved by day 14. the maximum tolerated dose will be maintained for the last 4 weeks of the study, unless dose adjustments are agreed with the sponsor. risperidone (1 to 3 mg or 4 to 6 mg) or placebo given orally as 0.5, 1, 2, 3, or 4 ,g tablets (or matching placebo) each day for 6 weeks.

Eligibility criteria:
inclusion criteria: * a responsible person must be available to accompany the subject to the site at each visit * patient must meet the dsm-iv criteria for schizophrenia exclusion criteria: * patients with mild, moderate or severe mental retardation * patients with a known or suspected history of substance dependence * subjects weighing \<35kg * subjects who cannot swallow oral tablets

Keywords: schizophrenia risperidone adolescents
financial incentives for smoking cessation

Conditions: Tobacco Use Disorder

Summary: the purpose of this study is to test the effectiveness of financial incentives for increasing long-term smoking cessation rates among employees at general electric worksites throughout the united states.

smoking is the leading cause of preventable mortality in united states, accounting for approximately 435,000 of the 2.4 million deaths each year in the united states. most smokers make multiple attempts to quit smoking, but only 2-3% succeed each year. smoking cessation programs have proven effective in helping smokers quit, but only about 5% of smokers enroll in smoking cessation programs each year. financial incentives have been shown to increase enrollment in smoking cessation programs and short-term quit rates, but have not been well tested as a mechanism for increasing long-term quit rates. the existing evidence suggests that they could be highly effective, particularly among heavy smokers and low income smokers. in addition, financial incentives for smoking cessation will likely be more cost effective than most covered health services and at least as cost effective as other recommended smoking cessation treatments. this study is a two-arm randomized clinical trial of financial incentives for smoking cessation among a sample of 850 male and female smokers from ge energy worksites throughout the u.s. smokers will be randomized to receive either usual care (information about local community-based smoking cessation resources, coverage of prescription drugs and physician visits) or usual care plus a package of financial incentives that includes $100 for completion of a community-based tobacco cessation program, $250 for short-term smoking cessation at either 3 months or 6 months after randomization, and $400 for smoking cessation 6 months post-quit date (biochemically confirmed).

Eligibility criteria:
inclusion criteria: * employees of general electric at work sites in the united states * current smokers who report having smoked at least 5 cigarettes per day for the prior 12 months * age 18 or older exclusion criteria: * current use of other tobacco products, such as chewing tobacco, pipes, or cigars * planning to leave general electric within the next 18 months

Keywords: smoking cessation work-site incentives cost effectiveness health behavior smoking
strength training effects on musculoskeletal health

Conditions: Musculoskeletal Diseases

Summary: the objective here is to assess the efficacy of variable resistance muscle training on bone, sleep parameters and quality of life in healthy populations of men and women age 30 or older.


Eligibility criteria:
inclusion criteria: * 30 years or older (males or females) * baseline strength (e.g., can lift an office chair with no problems) * be willing to participate in a 6-month rct * be willing to conduct daily muscle training exercises * be willing to maintain a food diary * be willing to consume \~2.2g/kg body weight daily * be willing to submit specimens and conduct tests 3 times over 6 months (0, 3 and 6 months) exclusion criteria: * those who consume vegan or vegetarian diets * people with conditions like hypertension and uncontrolled non-medicated blood pressure; cardiovascular disease/heart failure (e.g., arrhythmias, unstable angina, congestive heart failure) * copd * drugs that may increase fall risk or make dizzy (e.g., antidepressants, anti-seizure drugs) * muscle disease (e.g., myasthenia gravis, myopathy, myositis) * active hernia * pregnancy * muscle atrophy (e.g., duchenne muscular dystrophy (dmd), becker muscular dystrophy (bmd), als) * neuro degenerative disease * limited mobility * those who consume proteins supplements. * individuals who have implanted pacemakers or defibrillators * people who suffer from: marfan syndrome, migraine, hyperparathyroidism, metastatic bone disease, multiple myeloma * chronic steroid use * individuals with restrictions to movement and exercise
a comparative study in chinese subjects with chemotherapy naïve stage iv melanoma receiving ipilimumab (3 mg/kg) vs. dacarbazine

Conditions: Melanoma

Summary: the purpose of this study is to determine whether ipilimumab will extend the life of chinese patients with chemotherapy naive stage iv melanoma more than dacarbazine as well as to examine safety in this patient population.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * chinese males and females ≥ 18 years of age * histologic diagnosis of malignant melanoma * chemotherapy naive stage iv melanoma (ajcc 2010) * life expectancy of ≥ 16 weeks * eastern cooperative oncology group (ecog) performance status of 0 or 1 exclusion criteria: * evidence of brain metastases on brain imaging * primary ocular or mucosal melanoma * any other malignancy from which the patient has been disease-free for less than 5 years * braf status cannot be determined by screening test * human immunodeficiency virus (hiv) positive or hepatitis b surface antigen (hbsag) positive, or active hepatitis c infection